1.
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Who's Doing What in Molecular Diagnostics ? - The Results of the Kalorama
Information/Emmes Group Survey of U.S. Laboratories
April 1, 2009
From Kalorama Information a unique tool for assessing the diagnostic business today.
Working in conjunction with premier diagnostic survey database Emmes Group,
Kalorama Information presents the summarized results from a recent survey of a critical
mass of diagnostic labs in the U.S, with analysis from Kalorama's leading diagnostic
analyst, Shara Rosen.
Far more than any other market research report, this report provides the most current
and accurate picture of what is truly going on in molecular diagnostics in the United
States.
Quantitative Data
Analyzed by the best-selling author of The Worldwide Market for In Vitro Diagnostics,
now in its sixth edition, this new report includes surveys of molecular diagnostics
focusing on these tests:
• Chlamydia and Gonorrhea
• HBV Viral Load
• HCV Viral Load, HCV Genotyping
• HIV Viral Load, HIV Genotyping
• HPV, HPV Genotyping
• Hospital Acquired Infections - MRSA, VRE
• Coagulation Factors - Factor II, Factor V Leiden
• Herpes Simplex Virus (HSV)
• Oncology Tests - BCR/ABL, Bladder Cancer, Her2Neu, MTHFR
• Transplant Medicine - HLA Typing
• Hereditary Disorders - Cystic Fibrosis (CF), Fragile X
• Respiratory Infections - Influenza A/B, Group A Strep, MTB (Tuberculosis),
Bordetella pertussis, Adenovirus, Respiratory Virus
• Communicable Diseases - CMV (Cytomegalovirus), EBV (Epstein-Barr Virus),
Group B Strep, Enterovirus

2. What Labs Do Now, What They are Planning in the Future
There has been much analysis in recent years about the inroads that DNA testing has
made. This unique resource offers a way to measure that progress, and test
assumptions aobut the evolution of DNA testing, critical information to adjust business
stratetgies. This report looks at the following topics:
• What type of reagents are labs using (Commercial, ASR, Homebrew)
• Where tests are performed (Central/Core Testing Lab, Chemistry Lab, Cytology
Lab, Genetics Lab, Hematology Lab, Microbiology Lab, Molecular Lab, Pathology
Lab, Serology/Immunology Lab, Virology Lab)
• What Vendors are Labs Using
• What are there Purchasing Plans
• What Tests Do They Want in the Future
• Do They Outsource and at what Rate?
• Do They plan Vendor Changes?
A Representative Sample of the US Hospital Lab Industry
Emmes Group reached an extensive sample group - interviewing 14% of US hospital
labs, 14% of public labs and 8% of US reference lab, where Emmes respondent
numbers are compared to the Americian Hospital Directory. Such an undertaking would
cost an individual company tens of thousands of dollars. This information is available to
purchasers of this report at a fraction of the cost.
Table of Contents
CHAPTER ONE: EXECUTIVE SUMMARY
Background
Objectives of the Report
Scope of the Report
Methodology and Limitations of the Report
Survey Findings
CHAPTER TWO: OVERVIEW OF THE U.S. MARKET FOR SELECTED MOLECULAR
TESTS, 2008
Introduction
Overview of Company Market Share
Abbott Diagnostics
Access Genetics, LLC
BD Diagnostics/GeneOhm
bioMerieux
Cepheid
Gen-Probe Inc
Luminex Corp
Prodesse, Inc.
Qiagen/Digene

3. Roche Diagnostics
Siemens Healthcare Diagnostics
Third Wave Technologies Inc
Overview of the Market: Volume of Tests by Respondent
Overview of the Market: Reagent Type
Commercial, ASR, Homebrew
Overview of the Market: Type of Lab
Overview of the Market: Type of Institution
Market Potential
Explanation of Quantitative Data Extrapolation Formula
CHAPTER THREE: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR CHLAMYDIA AND GONORRHEA TESTS
Background
Market Breakdown: Vendor Market Share by End User
Market Breakdown by Type of Test Reagents Used
Market Breakdown by Lab Type
Summary and Conclusion
Anticipated Growth of the Market
CHAPTER FOUR: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR HEPATITIS C TESTS: HCV VIRAL LOAD, HCV GENOTYPING
Background
Hepatitis C Viral Load
Vendor Market Share by End User
Market Breakdown by Type of Test Reagents Used
Market Breakdown by Lab Type
Hepatitis C Genotyping
Vendor Market Share by End User
Market Breakdown by Type of Reagents Used
Market Breakdown by Lab Type
Summary and Conclusion
CHAPTER FIVE: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR HEPATITIS B VIRAL LOAD TESTS
Background
Vendor Market Share by End User
Market Breakdown by Type of Test Reagents Used
Market Breakdown by Lab Type
Summary and Conclusion
CHAPTER SIX: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR
HIV TESTS: HIV VIRAL LOAD AND HIV GENOTYPING
Background
HIV Viral Load Testing
Vendor Market Share by End User
Market Breakdown by Type of Test Reagents Used

4. Market Breakdown by Lab Type
HIV Genotyping
Vendor Market Share by End User
Market Breakdown by Type of Test Reagents Used
Market Breakdown by Lab Type
Summary and Conclusion
CHAPTER SEVEN: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR HPV TESTS: HPV, HPV GENOTYPING
Background
Human Papillomavirus (HPV)
Vendor Market Share by End User
Market Breakdown by Type of Test Reagents Used
HPV Genotyping
Summary and Conclusion
CHAPTER EIGHT: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR HOSPITAL
AQUIRED INFECTION TESTS: MOLECULAR MRSA AND VRE TESTS
Background
Methicillin-Resistant Staphylococcus aureus (MRSA)
Vendor Market Share by End User
Market Breakdown by Type of Test Reagents Used
Market Breakdown by Lab Type
Vancomycin Resistant Enterocci (VRE)
Summary and Conclusion
CHAPTER NINE: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR
COAGULATION GENE MARKER TESTS: FACTOR II PROTHROMBIN, FACTOR V
LEIDEN, AND MTHFR
Background
Factor V Leiden
Vendor Market Share by End User
Market Breakdown by Type of Test Reagents Used
Factor II Prothrombin
Vendor Market Share by End User
Market Breakdown by Type of Test Reagents Used
MTHFR (5,10-Methylenetetrahydrofolate Reductase)
Vendor Market Share by End User
Market Breakdown by Type of Test Reagents Used
Summary and Conclusion
CHAPTER TEN: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR HERPES SIMPLEX VIRUS (HSV TEST)
Background
Vendor Market Share by End User
Market Breakdown by Type of Test Reagents Used
Summary and Conclusion

5. CHAPTER ELEVEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR ONCOLOGY TESTS: BCR/ABL, BLADDER CANCER, AND HER2NEU
Background
BCR/ABL
Her-2/Neu
Bladder Cancer
Summary, and Conclusion
CHAPTER TWELVE: QUALITATIVE REVIEW OF THE U.S. MARKET FOR TISSUE
TYPING TESTS—HLA
Background
Findings, Summary and Conclusion
CHAPTER THIRTEEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR TESTS FOR INHERITED DISEASES: CYSTIC FIBROSIS (CF) AND
FRAGILE X SYNDROME
Background
Cystic Fibrosis (CF)
Fragile X
Summary and Conclusion
CHAPTER FOURTEEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR TESTS FOR RESPIRATORY INFECTIONS: INFLUENZA A/B, GROUP
A STREP, MTB (TUBERCULOSIS), BORDETELLA PERTUSSIS, ADENOVIRUS,
AND RESPIRATORY VIRUS
Background
Market Breakdown by Vendor Market Share
Summary and Conclusion
CHAPTER FIFTEEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR TESTS FOR COMMUNICABLE DISEASES: CMV
(CYTOMEGALOVIRUS), EBV (EPSTEIN-BARR VIRUS), GROUP B STREP, AND
ENTEROVIRUS
Background
Market Breakdown by Vendor Market Share
Summary and Conclusion
APPENDIX A: TESTS MOST DESIRED BY RESPONDENTS
If current limitations or barriers did not exist, what are the three molecular tests
that your lab would most like to add to its test menu in the next year?
APPENDIX B: TESTS LABS WILL ADD TO TEST MENU
Q: Is your lab seriously considering adding to its test menu in the next year or
two?
APPENDIX C: TESTS REQUESTED THAT LAB CANNOT OFFER

6. Q: Are there any molecular tests for which your lab receives more than a few rare
requests that you do not currently offer? If yes, which tests?
LIST OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: Respondents Compared to Broader Universe of Labs
Figure 1-1: Respondent Breakdown (Refence Labs, Public Labs, Hospital Labs)
Table 1-2: Respondents by Type of Lab, All Institutions (Microbiology, Molecular,
Central/Core, Virology, Chemistry/Clin Chem, Immunology, Anatomical
Pathology, Genetics, Serology, Cytology, Hematology)
Table 1-3: Database Respondents by Hospital Bed Size
CHAPTER TWO: OVERVIEW OF THE U.S. MARKET FOR SELECTED MOLECULAR
TESTS, 2008
Table 2-1: Worldwide Molecular Test Revenues of Selected IVD Vendors 2005-
2007
Table 2-2: Company Data Summary (Number of Analytes Reported, Volume of
Tests Reported, Percentage of Tests Reported, Tests per Analyte, Number of
Respondents, Percentage of Respondents, Tests per Respondent)
Table 2-3: Volume of Tests by Analyte (Annual Volume, Volume per Respondent,
Number of Respondents, Percent Respondents)
Table 2-4: Reagent Type (Commercial, ASR, Homebrew) by Analyte
Table 2-5: Respondents by Type of Lab (Microbiology, Molecular, Central/Core,
Virology, Chemistry/Clinical Chemistry, Immunology, Anatomic Pathology,
Genetics, Cytology, Serology, Hematology, Other)
Table 2-6: Analyte Testing Volume by Bed Size of Hospital and All Non-Hospital
Labs (Ref Lab)
Table 2-7: Distribution of Analyte Testing Bed Size of Hospital and All Non-
Hospital Labs (Ref Lab)
Table 2-8: Number of Respondent Labs Running Tests by Analyte and Bed Size
of Hospital and All Non Hospital Labs (Ref Lab)
Table 2-9: Percentage of Respondent Labs Running Tests by Analyte and Bed
Size of Hospital and All Non Hospital Labs (Ref Lab)
Table 2-10: Average Number of Tests per Year by Analyte and Bed Size of
Hospital and All Non Hospital Labs (Ref Lab)

7. Table 2-11: Most Cited Wish List Tests
Table 2-12: Most Cited Tests Likely Added to the Test Menu
Table 2-13: Tests Most Often Not Performed
Table 2-14: Top 8 Reasons for Not Offering Molecular Tests
CHAPTER THREE: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR CHLAMYDIA AND GONORRHEA TESTS
Table 3-1: Selected Molecular CT/GC Tests and Systems Available in the U.S.
(Company, Test)
Table 3-2: Average Number of CT/GC Molecular Tests per Year by Vendor and
by End User (Hospitals by Bed Size, Ref Labs, and Totals)
Table 3-3: Distribution of CT/GC Molecular Test Volume by Vendor and End
User (Hospitals by Bed Size, Ref Labs, and Totals)
Table 3-4: Number of Respondent Labs Using CT/GC Molecular Tests by Vendor
and End User(Hospitals by Bed Size, Ref Labs, and Totals)
Table 3-5: Breakdown of CT/GC Molecular Tests by Vendor and End User
(Hospitals by Bed Size, Ref Labs)
Table 3-6: Breakdown of CT/GC Molecular Tests by Vendor and End User
(Hospitals by Bed Size, Ref Labs)
Table 3-7: Number of Respondents Who Use Homebrew CT/GC Molecular Tests
by Size of Hospital and All Non-Hospital Labs (Ref Lab)
Table 3-8: Test Volume of Homebrew CT/GC Molecular Tests by Size of Hospital
and All Non-Hospital Labs (Ref Lab)
Table 3-9: Breakdown of CT/GC Molecular Tests by Lab Type (Microbiology,
Molecular, Core Lab, Virology, Chemistry, Immunology, Serology, Other):
Number of Respondents and Total Testing Volume
Table 3-10: Breakdown of CT/GC Molecular Testing in Core Labs and Chemistry
Labs by Hospital Bed Size or Ref Labs
Table 3-11: Technology Change Responses
CHAPTER FOUR: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR HEPATITIS C TESTS: HCV VIRAL LOAD, HCV GENOTYPING
Table 4-1: Selected HCV Tests and Systems Available in the United States

8. Table 4-2: Number of HCV Viral Load Tests by Vendor and End User (Hospitals
by Bed Size, Ref Labs)
Table 4-3: Percentage of Respondents Using HCV Viral Load Tests by Vendor
and End User (Hospitals by Bed Size, Ref Labs)
Table 4-4: Number of Respondents Using HCV Viral Load Tests by Vendor and
End User (Hospitals by Bed Size, Ref Labs)
Table 4-5: Distribution of Respondents Reporting HCV Viral Load Tests by
Vendor and End User (Hospitals by Bed Size, Ref Labs)
Table 4-6: Number of HCV Viral Load Tests by Vendor and End User (Hospitals
by Bed Size, Ref Labs)
Table 4-7: Number of Respondents and Test Volume of Labs Using ASRs for
HCV Viral Load by End User (Hospitals by Bed Size and All Non-Hospital Labs
[Ref Lab])
Table 4-8: Number of Respondents and Test Volume for HCV Viral Load Testing
by Lab Type (Molecular, Microbiology, Virology, Core Lab, Immunology,
Chemistry, Serology, Other)
Table 4-9: Respondents, Test Volume, and Average Number of Tests for HCV
Viral Load Testing by Lab Type (Molecular, Microbiology, Virology, Core Lab,
Immunology, Chemistry, Serology, Other)
Table 4-10: Number of HCV Genotyping Tests by Vendor and End User
(Hospitals by Bed Size, Ref Labs)
Table 4-11: Distribution of HCV Genotyping Tests by Vendor and End User
(Hospitals by Bed Size, Ref Labs)
Table 4-12: Number of Respondents Using HCV Genotyping Tests by Vendor
and End User (Hospitals by Bed Size, Ref Labs)
Table 4-13: Distribution of Respondents Using HCV Genotyping Tests by Vendor
and End User (Hospitals by Bed Size, Ref Labs)
Table 4-14: Selected HCV Genotyping Products Available in the United States
Table 4-15: Number of HCV Viral Load Tests by Vendor and End User (Hospitals
by Bed Size, Ref Labs)
Table 4-16: Number of Respondents Performing HCV Viral Load Tests by Type
of Reagents (Commercial Test, ASR, Homebre) by Vendor

9. Table 4-17: Number of Respondents and Testing Volume of HCV Genotyping
Tests by Lab Type (Molecular, Microbiology, Virology, Other)
Table 4-18: Respondents, Test Volume, and Average Number of Tests for HCV
Genotype Testing by Lab Type (Molecular, Microbiology, Virology, Other)
Table 4-19: Number Respondents Using HCV Viral Load AND Genotype Tests
by Vendor (Abbott, ABI-700, Roche, Siemens, PCR)
CHAPTER FIVE: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR HEPATITIS B VIRAL LOAD TESTS
Table 5-1: Selected Molecular HBV Tests and Systems Available in the United
States
Table 5-2: Number of HBV Viral Load Tests by Vendor and End User (Hospitals
by Bed Size, Ref Labs)
Table 5-3: Distribution of Respondents Reporting HBV Viral Load Test Use by
Vendor and End User (Hospitals by Bed Size, Ref Labs)
Table 5-4: Number of Respondents Using HBV Viral Load Tests by Vendor
(Roche, Siemens, Digene, Other) and End User (Hospitals by Bed Size, Ref
Labs)
Table 5-5: Percent of Respondents Using HBV Viral Load Tests by Vendor
(Roche, Siemens, Digene, Other) and End User (Hospitals by Bed Size, Ref
Labs)
Table 5-6: Number of HBV Viral Load Tests by Vendor (Roche, Digene,
Siemens, Other) and End User (Hospitals by Bed Size, Ref Labs)
Table 5-7: Number and Distribution of Respondents Reporting Use of HBV Viral
Load Tests by Vendor (Roche, Siemens, Abbott, Qiagen, Digene, PCR) and
Type of Reagents (Commercial, ASR, Homebrew)
Table 5-8: Testing Volume and Number of Respondents Using HBV Viral Load
Tests by Lab Type (Molecular, Microbiology, Virology, Other)
Table 5-9: Breakdown of HBV Viral Load Tests by Lab Type (Molecular,
Microbiology, Virology, Other): Number of Respondents, Total Testing Volume,
and Average Number of Tests
CHAPTER SIX: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR MOLECULAR
HIV TESTS: HIV VIRAL LOAD AND HIV GENOTYPING
Table 6-1: Selected FDA Cleared Molecular HIV Tests Available in the United
States

10. Table 6-2: Number of HIV Viral Load Tests by Vendor (Roche, Siemens, Abbott,
bioMerieux, PCR) and End User (Hospitals by Bed Size, Ref Labs)
Table 6-3: Distribution of HIV Viral Load Testing by Vendor (Roche, Siemens,
Abbott, bioMerieux, PCR) and End User (Hospitals by Bed Size, Ref Labs)
Table 6-4: Number of Respondents Using HIV Viral Load Tests by Vendor
(Roche, Siemens, Abbott, bioMerieux, PCR) and End User (Hospitals by Bed
Size, Ref Labs)
Table 6-5: Distribution of Respondents Using HIV Viral Load Tests by Vendor
(Roche, Siemens, Abbott, bioMerieux, PCR) and End User (Hospitals by Bed
Size, Ref Labs)
Table 6-6: Number of HIV Viral Load Tests by Vendor by Vendor (Roche,
Siemens, Abbott, bioMerieux, PCR) and End User (Hospitals by Bed Size, Ref
Labs)
Table 6-7: Number of Respondents Reporting Use of HIV Viral Load Tests by
Type of Reagents Used (Commercial Test, ASR, Homebrew)
Table 6-8: Number of Respondents and Total Test Volume of HIV Viral Load
Tests by Lab Type (Molecular, Microbiology, Virology, Core/Chemistry, Other)
Table 6-9: Total Testing Volume of HIV Viral Load Tests and Average Number of
Tests by Lab Type (Molecular, Microbiology, Virology, Core/Chemistry, Other)
Table 6-10: Number of HIV Genotyping Tests by Vendor (Roche, Siemens,
Abbott, Other) and End User (Hospitals by Bed Size, Ref Labs)
Table 6-11: Distribution (Share) of Genotyping Tests by Vendor (Roche,
Siemens, Abbott, Other) and End User (Hospitals by Bed Size, Ref Labs)
Table 6-12: Number Respondents Using of HIV Genotyping Tests by Vendor
(Roche, Siemens, Abbott, Other) and End User (Hospitals by Bed Size, Ref
Labs)
Table 6-13: Distribution of Respondents Using of HIV Genotyping Tests by
Vendor (Roche, Siemens, Abbott, Other) and End User (Hospitals by Bed Size,
Ref Labs)
Table 6-14: Average Number of HIV Genotype Tests by Vendor (Roche,
Siemens, Abbott, Other) and End User (Hospitals by Bed Size, Ref Labs)
Table 6-15: Number of Respondents Using HIV Viral Load Tests by Type or
Reagent (Commercial, ASR, Homebrew)

11. Table 6-16: Number of Respondents, Total Testing Volume, and Average Numer
of Tests of HCV Genotyping Tests by Lab Type
Table 6-17: Number Respondents Using HIV Viral Load AND Genotype Tests by
Vendor (Abbott, Roche, Siemens, PCR)
CHAPTER SEVEN: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR HPV TESTS: HPV, HPV GENOTYPING
Table 7-1: Selected Molecular HPV Tests
Table 7-2: Number of HPV Tests by Vendor (Qiagen/Digene, Hologic/Third
Wave, Other) and End User (Hospital Lab by Bed Size, Ref Lab)
Table 7-3: Distribution of HPV Tests by Vendor (Qiagen/Digene, Hologic/Third
Wave, Other) and End User (Hospital Lab by Bed Size, Ref Lab)
Table 7-4: Number of Respondents Using HPV Tests by Vendor (Qiagen/Digene,
Hologic/Third Wave, Other) and End User (Hospital Lab by Bed Size, Ref Lab)
Table 7-5: Distribution of HPV Tests by Vendor (Qiagen/Digene, Hologic/Third
Wave, Other) and End User (Hospital Lab by Bed Size, Ref Lab)
Table 7-6: Average Number of HPV Tests Performed by Vendor (Qiagen/Digene,
Hologic/Third Wave, Other) and End User (Hospital Lab by Bed Size, Ref Lab)
Table 7-7: Number of Repondents Using HPV Tests by Vendor (Access
Genetics, Cepheid, Qiagen/Digene, Roche, Siemens, Hologic/Third Wave, PCR)
and Type of Reagent (Commercial, ASR, Homebrew)
Table 7-8: Number of Respondents Using HPV Genotyping Tests by Vendor and
Lab Type (Hospital vs Reference)
Table 7-9: Number of HPV Genotyping Tests Performed by Vendor and Lab
Type (Hospital vs Reference)
CHAPTER EIGHT: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR HOSPITAL
AQUIRED INFECTION TESTS: MOLECULAR MRSA AND VRE TESTS
Table 8-1: Percentage of Staph Infections among U.S. Intensive Care Patients
That Are Infected with MRSA
Table 8-2: Selected Molecular MRSA Tests and Systems Available in the U.S.
Table 8-3: Number of Molecular MRSA Tests by Vendor (BD/Gene Ohm,
Cepheid, Roche, Other) and End User (Hospitals by Bed Size, Ref Lab)

12. Table 8-4: Distribution ofMolecular MRSA Test Volume by Vendor
(BD/GeneOhm, Cepheid, Roche, Other) and End User (Hospitals by Bed Size,
Ref Lab)
Table 8-5: Number of Respondents Using Molecular MRSA Tests by Vendor
(BD/GeneOhm, Cepheid, Roche, Other) and End User (Hospitals by Bed Size,
Ref Lab)
Table 8-6: Distribution of Respondents Using Molecular MRSA Tests by Vendor
(BD/GeneOhm, Cepheid, Roche, Other) and End User (Hospitals by Bed Size,
Ref Lab)
Table 8-7: Average Number of Molecular MRSA Tests by Vendor (BD/GeneOhm,
Cepheid, Roche, Other) and End User (Hospitals by Bed Size, Ref Lab) and End
User
Table 8-8: Number of Respondents Using MRSA Tests by Vendor
(BD/GeneOhm, Cepheid, Roche, Other, PCR) and Type of Reagents
(Commercial, ASR, Homebrew)
Table 8-9: Number of Respondents and Total Testing Volume of MRSA Tests by
Lab Type (Microbiology, Molecular, Core/Chem Lab, Virology, Other)
Table 8-10: Average Number of MRSA Tests Run by Lab Type (Microbiology,
Molecular, Core Lab, Virology, Other)
Table 8-11: Number of Respondents and Testing Volume of VRE Tests by
Vendor in Hospital Labs
CHAPTER NINE: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR
COAGULATION GENE MARKER TESTS: FACTOR II PROTHROMBIN, FACTOR V
LEIDEN, AND MTHFR
Table 9-1: FDA-Cleared Molecular Coagulation Factor Tests
Table 9-2: Number of Factor V Molecular Tests by Vendor (Roche, Third Wave,
Nanosphere, Other) and End User (Hospitals by Bed Size, Ref Lab)
Table 9-3: Distrubution of Factor V Molecular Test Volume by Vendor (Roche,
Third Wave, Nanosphere, Other) and End User (Hospitals by Bed Size, Ref Lab)
Table 9-4: Number of Respondents Using Factor V Molecular Tests by Vendor
(Roche, Third Wave, Nanosphere, Other) and End User (Hospitals by Bed Size,
Ref Lab)
Table 9-5: Distribution of Respondents Using Factor V Molecular Tests by
Vendor (Roche, Third Wave, Nanosphere, Other) and End User (Hospitals by
Bed Size, Ref Lab)

13. Table 9-6: Average Number of Factor V Molecular Tests by Vendor (Roche,
Third Wave, Nanosphere, Other) and End User (Hospitals by Bed Size, Ref Lab)
Table 9-7: Number of Respondents Using Factor V Molecular Tests by Reagent
Type (Commercial, ASR, Homebrew)
Table 9-8: Number of Factor II Molecular Tests by Vendor (Roche, Third Wave,
Nanosphere, Other) and End User (Hospitals by Bed Size, Ref Lab)
Table 9-9: Distribution of Factor II Molecular Tests by Vendor (Roche, Third
Wave, Nanosphere, Other) and End User (Hospitals by Bed Size, Ref Lab)
Table 9-10: Number of Respondents Using Factor II Molecular Tests by Vendor
(Roche, Third Wave, Nanosphere, Other) and End User (Hospitals by Bed Size,
Ref Lab)
Table 9-11: Distribution of Respondents Using Factor II Molecular Tests by
Vendor and End User
Table 9-12: Average Number of Factor II Molecular Tests by Vendor (Roche,
Third Wave, Nanosphere, Other) and End User (Hospitals by Bed Size, Ref Lab)
Table 9-13: Number of Respondents Using Factor II Molecular Tests by Reagent
Type (Commerical Test, ASR, Homebrew)
Table 9-14: Number of MTHFR Gene Tests by Vendor (Third Wave,
Nanosphere, PCR, Other) and End User (Hospitals by Bed Size, Ref Lab)
Table 9-15: Distribution of MTHFR Gene Tests by Vendor (Third Wave,
Nanosphere, PCR, Other) and End User (Hospitals by Bed Size, Ref Lab)
Table 9-16: Number of Respondents Using MTHFR Gene Tests by Vendor (Third
Wave, Nanosphere, PCR, Other) and End User (Hospitals by Bed Size, Ref Lab)
Table 9-17: Distribution of Respondents Using MTHFR Gene Tests by Vendor
(Third Wave, Nanosphere, PCR, Other) and End User (Hospitals by Bed Size,
Ref Lab)
Table 9-18: Average Number of MTHFR Gene Tests by Vendor (Third Wave,
Nanosphere, PCR, Other) and End User (Hospitals by Bed Size, Ref Lab)
Table 9-19: Number of Respondents Using MTHFR Gene Tests by Reagent
Type (Commercial, ASR, Homebrew)
Table 9-20: Number and Percentage of Respondents Performing a Mix of
Coagulation Gene Test by Mix (Factor V/Factor II vs Factor V/FactorII/MTHFR)
and by End User (Hospital by Bed Size and Reference Labs)

14. CHAPTER TEN: QUANTITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR HERPES SIMPLEX VIRUS (HSV TEST)
Figure 10-1: Genital Herpes, Initial Visits to Physicians' Offices, National Disease
and Therapeutic Index: United States, 1966-2007
Table 10-1: Selected Molecular HSV Tests Available in the United States
Table 10-2: Number of HSV Molecular Tests by Vendor (Cepheid, Qiagen,
Roche, PCR, Other) and End User (Hospital by Bed Size and Refence Lab)
Table 10-3: Distribution of HSV Molecular Tests by Vendor (Cepheid, Qiagen,
Roche, PCR, Other) and End User (Hospital by Bed Size and Refence Lab)
Table 10-4: Number of Respondents Using HSV Molecular Tests by Vendor
(Cepheid, Qiagen, Roche, PCR, Other) and End User (Hospital by Bed Size and
Refence Lab)
Table 10-5: Distribution of Respondents Using HSV Molecular Tests by Vendor
(Cepheid, Qiagen, PCR, Other) and End User (Hospital by Bed Size and
Refence Lab)
Table 10-6: Average Number of HSV Molecular Tests by Vendor (Cepheid,
Qiagen, Roche, PCR, Other) and End User (Hospital by Bed Size and Refence
Lab)
Table 10-7: Number of Respondents Using HSV Molecular Tests by Reagent
Type (Commercial Test, ASR, Homebrew)
CHAPTER ELEVEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR ONCOLOGY TESTS: BCR/ABL, BLADDER CANCER, AND HER2NEU
Table 11-1: Selected Molecular Oncology Tests Available in the United States
Table 11-2: Testing Volume of Molecular Oncology Tests by Vendor (Abbott,
Roche, PCR, Other) and Analyte (BCR/ABL, Bladder Cancer, Her2Neu)
Table 11-3: Number of Respondents Using Molecular Oncology Tests by Vendor
(Abbott, Roche, PCR, Other) and Analyte (BCR/ABL, Bladder Cancer, Her2Neu)
CHAPTER THIRTEEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR TESTS FOR INHERITED DISEASES: CYSTIC FIBROSIS (CF) AND
FRAGILE X SYNDROME
Table 13-1: Selected Diseases that Have a Genetic Component
Table 13-2: Selected CF Tests Available in the U.S., 2008

15. Table 13-3: Number of CF Gene Tests by Vendor (Third Wave, Luminex, Other)
and End User (Hospitals by Bed Size and Ref Lab)
Table 13-4: Distribution of CF Gene Tests by Vendor (Third Wave, Luminex,
Other) and End User (Hospitals by Bed Size and Ref Lab)
Table 13-5: Number of Respondents Using CF Gene Tests by Vendor (Third
Wave, Luminex, Other) and End User (Hospitals by Bed Size and Ref Lab)
Table 13-6: Distribution of Respondents Using CF Gene Tests by Vendor (Third
Wave, Luminex, Other) and End User (Hospitals by Bed Size and Ref Lab)
Table 13-7: Number of Tests and and Respondents Using Fragile X Tests by
End User (Hospital by Bed Size and Refererence Lab)
Table 13-8: Number of Tests and Number of Respondents Using Fragile X Tests
by Type of Reagents (PCR vs Other)
CHAPTER FOURTEEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR TESTS FOR RESPIRATORY INFECTIONS: INFLUENZA A/B, GROUP
A STREP, MTB (TUBERCULOSIS), BORDETELLA PERTUSSIS, ADENOVIRUS,
AND RESPIRATORY VIRUS
Table 14-1: Selected FDA-Cleared Molecular Respiratory Infection Tests
Table 14-2: Number of Molecular Respiratory Infection Tests by Organism (Strep
A, Bordetella, Influenza A/B, TB, Adenovirus, Respiratory Virus) and by Vendor
(BD/GeneOhm, bioMerieux, Cepheid, Gen-Probe, Luminex, Prodesse, Qiagen,
Roche, PCR, Other)
Table 14-3: Distribution of Molecular Respiratory Infection Tests by Organism
(Strep A, Bordetella, Influenza A/B, TB, Adenovirus, Respiratory Virus) and by
Vendor (BD/GeneOhm, bioMerieux, Cepheid, Gen-Probe, Luminex, Prodesse,
Qiagen, Roche, PCR, Other)
Table 14-4: Number of Respondents Using Molecular Respiratory Infection Tests
by Organism (Strep A, Bordetella, Influenza A/B, TB, Adenovirus, Respiratory
Virus) and by Vendor (BD/GeneOhm, bioMerieux, Cepheid, Gen-Probe,
Luminex, Prodesse, Qiagen, Roche, PCR, Other)
Table 14-5: Distribution of Respondents Using Molecular Respiratory Infection
Tests by Organism (Strep A, Bordetella, Influenza A/B, TB, Adenovirus,
Respiratory Virus) and by Vendor (BD/GeneOhm, bioMerieux, Cepheid, Gen-
Probe, Luminex, Prodesse, Qiagen, Roche, PCR, Other)
Table 14-6: Average Number of Molecular Respiratory Infection Tests by
Organism (Strep A, Bordetella, Influenza A/B, TB, Adenovirus, Respiratory Virus)

16. and by Vendor (BD/GeneOhm, bioMerieux, Cepheid, Gen-Probe, Luminex,
Prodesse, Qiagen, Roche, PCR, Other)
Table 14-7: Market Growth Data: Estimated Test Volume Increase by Organism
(Strep A, Bordetella, Influenza A/B, TB, Adenovirus, Respiratory Virus)
CHAPTER FIFTEEN: QUALITATIVE REVIEW OF THE U.S. MARKET FOR
MOLECULAR TESTS FOR COMMUNICABLE DISEASES: CMV
(CYTOMEGALOVIRUS), EBV (EPSTEIN-BARR VIRUS), GROUP B STREP, AND
ENTEROVIRUS
Table 15-1: Number of Molecular Communicable Disease Tests by Organism
(CMV, EBV, Strep B, Enterovirus) and Vendor (Abbott, BD/GeneOhm, Cepheid,
Gen-Probe, Qiagen, Roche, PCR, Other)
Table 15-2: Distribution of Molecular Communicable Disease Tests by Organism
(CMV, EBV, Strep B, Enterovirus) and Vendor (Abbott, BD/GeneOhm, Cepheid,
Gen-Probe, Qiagen, Roche, PCR, Other)
Table 15-3: Number of Respondents Using Molecular Communicable Disease
Tests by Organism (CMV, EBV, Strep B, Enterovirus) and Vendor (Abbott,
BD/GeneOhm, Cepheid, Gen-Probe, Qiagen, Roche, PCR, Other)
Table 15-4: Distribution of Respondents Using Molecular Communicable Disease
Tests by Organism (CMV, EBV, Strep B, Enterovirus) and Vendor (Abbott,
BD/GeneOhm, Cepheid, Gen-Probe, Qiagen, Roche, PCR, Other)
Table 15-5: Average Number of Molecular Communicable Disease Tests by
Organism (CMV, EBV, Strep B, Enterovirus) and Vendor (Abbott, BD/GeneOhm,
Cepheid, Gen-Probe, Qiagen, Roche, PCR, Other)
Table 15-6: Market Growth Data: Estimated Test Volume Increase by Organism
(CMV, EBV, Strep B, Enterovirus)
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